CytomX Therapeutics, inc (CTMX) Q2 2021 Earnings Call Transcript

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CytomX Therapeutics, inc (CTMX -1.84%)
Q2 2021 Earnings Call
Aug 6, 2021, 5:00 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the CytomX Therapeutics Second Quarter 2021 Financial Results Call. Please be advised that today's call is being recorded. I would now like to hand the conference over to your host for today, Chau Cheng, CytomX Vice President, Investor Relations and Corporate Communications. Please go ahead.

Chau Cheng -- Vice President, Investor Relations and Corporate Communications

Thank you, Susan. Good afternoon, and thank you for joining us. With me today are Dr. Sean McCarthy, CytomX's President, Chief Executive Officer and Chairman; Dr Amy Peterson, Chief Development Officer; and Carlos Campoy, Chief Financial Officer. Earlier today, we issued a press release that includes a summary of our second quarter 2021 financial results and highlights the important progress we made during the quarter. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC. Additionally, the press release and the recording of this call can be found under the Investors and News section of our website at cytomx.com.

During today's call, we will be making forward-looking statements. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks, including the uncertainties surrounding the COVID-19 pandemic that are difficult to predict and many of which are outside of our control. Important risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov, including our Form 10-Q filed today. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future developments or otherwise.

With that, I'd like to turn the call now over to Sean.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Thank you, Chau, and good afternoon everyone. Thanks for joining us today for an update on recent progress and developments within our clinical and preclinical programs and operations. At CytomX, we continue to dedicate ourselves to working toward making a meaningful difference in cancer treatment by being different and thinking differently. We have pioneered an entirely new way to design therapeutic antibodies and other biologic modalities and we have used our technology to purposefully go off to high potential targets that were previously considered undruggable in order to stand out from the crowd and build long-term value.

We are exploiting an Achilles' heel of tumor biology to combat cancer in new and unique ways. Our technology of the Probody platform is a conditional activation strategy that uses protease-dependent peptide molecule. Given that proteases are activated in the tumor microenvironment, but tightly controlled in normal tissues. Our strategy is designed to reduce antibody binding in normal tissues while maximizing target binding in cancer. During the second quarter, we continue to advance our broad pipeline of Probody therapeutics across multiple modalities and cancer sites including our two conditionally activated antibody-drug conjugates or ADCs, praluzatamab ravtansine also known as CX-2009 and CX-2029, both of which are currently in Phase 2 clinical investigations encompassing multiple tumor types.

Let me begin with CX-2029 or CD71 directed conditionally activated ADC for which we recently published results from a Phase I first in human study in patients with advanced solid tumors. This important work by CytomX in collaboration with our partner AbbVie has demonstrated for the first time the CD71 can be successfully targeted with a drug-conjugated antibody using our technology by CD71. While CD71 or the transparent receptor has been a very attractive, but elusive oncology target for ADC development. It's highly expressed on the vast majority achievers, so it's all growing and dividing cells, need iron for many metabolic processes. And CD71 is an extremely efficient transport system, fully internalizing antibodies within minutes of finding. However, CD71 was previously deemed un-druggable with conventional ADC, because it's also highly expressed in and vital to normal tissue growth and development.

As we have now published in Clinical Cancer Research in the Phase I dose escalation CX-2029 was generally well tolerated and produced encouraging anti-cancer activity, mostly in patients with squamous, non-small cell lung and head and neck cancer, at first for an ADC against this high potential target. These two cancer sites are now part of an ongoing four cohorts Phase II expansion study. We dosed the first patients in the expansion phase in November 2020, and then we will give you an update in a few months [Indecipherable].

Moving on to praluzatamab ravtansine, our wholly owned first-in-class conditionally activated ADC directed toward another novel oncology target CD166. CD166 also known as activated leukocyte cell adhesion molecule or ALCAM is a transmembrane glycoprotein that has been reported to play a role in multiple aspects of tumor biology including angiogenesis and biogenesis. CD166 is highly expressed on the cell surface of many cancer sites and as such as attractive molecular properties as an ADC target. However, developing a conventional ADC as CD166 is precluded by its widespread presence on healthy tissues.

Our pioneering Phase I clinical work on CD166 has shown that praluzatamab can achieve clinically meaningful outcomes in patients with different cancer types, including but not limited to HER2 non-amplified breast cancer. These results support our current 3-arm Phase II study in breast cancer and we're excited about the potential for this asset in this indication and more broadly in other CD166 expressing cancers where substantial unmet need remains. Amy will also provide you with more details of the design and status of the praluzatamab Phase II study shortly.

Turning back briefly to our work in immuno-oncology and our partner clinical programs with Bristol-Myers Squibb aimed at broadening the therapeutic window and therefore the clinical utility of anti-CTLA-4 immunotherapy.

BMS-986249 and BMS-986288 discovered using the CytomX platform, our Probody versions of different forms of the anti-CTLA-4 therapeutic antibody ipilimumab. BMS-986249 having successfully completed dose escalation, is currently being evaluated in a randomized Phase II study in combination with the anti-PD-1 antibody nivolumab in patients with metastatic melanoma. Importantly, the control arm in this study is NIVO plus ipilimumab rather than NIVO monotherapy representing the current standard of care based on 5-year followup from CheckMate 0.67, which showed a significant increase in overall survival with this combination in melanoma over NIVO monotherapy. BMS-986249 is also being studied in combination with NIVO in three additional advanced settings, hepatocellular carcinoma, castration-resistant prostate cancer and triple-negative breast cancer.

BMS-986288, a Probody version of a non-fucosylated ipilimumab with increased T-reg depletion properties continues to be evaluated in a Phase I study in advanced solid cancers as monotherapy and in combination with NIVO.

Switching now to our research and preclinical programs in the field of conditionally activated T-cell bispecific antibodies. We see a major opportunity here to improve the therapeutic window of this modality using our platform and we are pursuing multiple projects with our partners, Amgen and Astellas.

CX-904 is a conditionally activated T-cell engaging bispecific directed against EGFR on tumor cells and CD3 on T-cells, and this is an IND enabling studies. We recently submitted a pre-IND meeting request to the FDA and we expect written responses to our questions from the regulatory agencies in the third quarter of this year. We will continue to discuss program with our partner Amgen and we are working toward the filing of an IND for CX-904 in late 2021.

Q2 was also highly productive for CytomX in terms of publication of our work in peer-reviewed journals. A totaled of five manuscripts were recently published covering our work, the ranges from stage I investigation of CX-2029 as I have already mentioned, so multiple publications describing our clinical work with pacmilimab or CX-072, our wholly owned conditionally activated antibody against PD-L1.

Our particular note on our recent collaborative work with Dr. Elizabeth de Vries of the University Medical Center, Groningen in the Netherlands has investigated the biodistribution of pacmilimab in cancer patients using clinical imaging. This study is an important light on the molecular performance of the Probody platform in cancer patients, including the direct demonstration of activation and binding pacmilimab to primary and metastatic tumors.

Another recent publication of particular note is our landmark preclinical study of a Probody immuno-oncology agonist in the preceding to the National Academy of Sciences. As you will recall, we introduced earlier this year our advancement of our conditional activation technology in the Cytomx space. [Indecipherable] they think even further as the first published application on the CytomX platform to agonist antibody in immuno-oncology emphasizing the versatility of our platform.

And typically, together with our collaborators, we have shown in this publication that an anti-CD137 Probody with a purpose antitumor activity with significantly reduced liver toxicity compared with unmasked antibody when assessed in the same mass model system. This is exactly what our platform is designed to do. [Indecipherable] includes extensive characterization of Probody activation by [Indecipherable]. Together these publications underscore the immense progress we've made across our pipeline and platform with our first generations of Probody therapeutics, a field that CytomX has defined and continues to lead and we continue to innovate on the core platform and across many therapeutic modalities.

Let me now hand the call over to Amy for additional detail and updates on our lead clinical programs.

Amy C. Peterson, M.D. -- Executive Vice President, Chief Development Officer

Thanks, John. I'll start with a quick recap of the design for our Phase II studies of CX-2029 and praluzatamab. The CX-2029 in collaboration with AbbVie, we continue to enroll patients in the expansion phase of this Phase one-2 study designed to evaluate the CD-71 directed conditionally activated ADC in four different cohorts, squamous non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal and gastroesophageal junction cancers and diffuse large B-cell lymphoma. Each cohort aims to enroll up to 25 efficacy evaluable patients and we continue to expect initial data from the expansion phase of the study in the fourth quarter of this year.

Switching to CX-2009 or praluzatamab ravtansine, we are evaluating the CD156 directed conditionally activated ADC as monotherapy in patients with HER2 non-amplified breast cancer, which includes hormone receptor positive Arm A and triple-negative breast cancer Arm B. We are also evaluating the combination with our proprietary anti-PD-L1 therapeutic pacmilimab in patients with triple-negative disease in Arm C. The goal is to reach 40 efficacy evaluable patients in each of these arms and the primary endpoint of this study is overall response rates according to resist. Secondary endpoints include duration of response and clinical benefit rate at 24 weeks, the latter being particularly an important metric for the former and receptor positive in subtypes, as it has a reasonable surrogate support progression-free survival endpoint in future studies.

Enrollment is ongoing, however, our accrual rate for the fourth quarter 2021 initial data readout has been slower than expected, due primarily to the widespread effects of the COVID 19 pandemic on site activation and patient enrollment. The praluzatamab Phase II study is a new trial requiring de novo site activation, and this has proven particularly challenging in the current environment. As such, we now anticipate initial data from this study in 2022. Notwithstanding the COVID 19 challenges, we continue to implement ways to help improve the pace of patient enrollment including opening additional sites in U.S., Europe and Asia as well as partnering with patient advocacy groups to encourage enrollment from underrepresented populations, given the fact that triple-negative breast cancer is more prevalent in minority women. We are excited about the opportunity for praluzatamab in breast cancer and I would like to take a few moments to look ahead to where this drug candidate has the potential to fit into the treatment landscape.

Recall that historically breast cancer has been divided into three major sub-types and treatment have been developed accordingly. ER/PR positive, which is responsive to just hormonal therapy; HER2 amplified, which is responsive to HER-2 targeted therapies; and triple-negative breast cancer named not for what it is, but rather what it is not and is therefore heterogeneous recruitment. Before turning the call over to Carlos to review our financials, I want to point out that in our Phase II study effectively we are evaluating praluzatamab in HER2 non-amplified breast cancer, an emerging classification that compliance hormone receptor positive with triple-negative breast cancer and represents approximately 80% of all breast cancer and includes those that express both low and no levels of HER2 by IHC. It's also important to note that CD156 expression is found across all of these sub-classifications of breast cancer. And thus, CX-2009 represents a significant opportunity.

Carlos Campoy -- Senior Vice President and Chief Financial Officer

Thank you, Amy. With $366 million in cash, cash equivalents and investments as of June 30, 2021. CytomX remains well capitalized to support our bold clinical and research agenda that will drive the growth of the company well into 2023. Revenue was $16 million for the second quarter of 2021, relatively flat when compared to the corresponding period in 2020. R&D expenses increased $2 million to $26 million during the three months ended on June 30, 2021, compared to the corresponding period in 2020. The increase was driven mainly by timing of manufacturing and translational science activities. G&A expenses were $9 million for Q2 2021, essentially flat compared to the second quarter 2020.

With that, I'll turn the call back to Sean.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Thanks, Carlos and thanks to everyone for joining us today. To briefly recap, CytomX continue to make broad progress in Q2 across our pipeline and platform. We currently have four novel property assets in Phase II studies across nine cancer types, with regards to starting at the end of this year with CX-2029. We also continue to develop our core technology across multiple biologic modalities as we advance new clinical candidates to develop. Our recently published work highlights the scope and scale of our R&D efforts as we drive our pipeline forward and invest in our technology for the long term.

With that, let's open up the call for questions. I'll turn it back to the operator.

Questions and Answers:

Operator

{Operator Instruction]. Our first question comes from the line of Anupam Rama from JP Morgan. Your line is now open.

Anupam Rama -- JP Morgan

Hey, guys. Thanks so much for taking the question. For CX-2029, can you remind us the size and scope of the data will be getting here in 4Q and remind us if this is going to be at a medical meeting or should we be thinking about more of a top line press release webcast type scenario? Thanks so much.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah. Hey, Anumpama. [Indecipherable]. So we're guiding to initial data from the expansion phase by the end of the year. We haven't pinpointed any particular venue or method through which we would communicate that data. As Amy mentioned there are four cohorts in this expansion phase, the head and neck, the lung, the esophageal and the DLBCL. We are anticipating initial data from at least one of these cohorts by the end of this year. We're on track, and as I said, we haven't guided exactly where that would be.

Anupam Rama -- JP Morgan

Thanks for taking our question.

Operator

Our next question comes from the line of Roger Song from Jefferies. Your line is now open.

Roger Song -- Jefferies LLC -- Analyst

Great, thank you. Very similarly the question for that CX-2009. So what should we expect in the initial readout, because I remember last quarter you say the initial data from the Arm 1 and B -- A and B and that should we also expect to Arm A and B as the initial data. Also you broadly guide to 2022, can we have some granularity in terms of first half or second half of 2022, when should we be expecting the data?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah. Hi, Roger. Back to the question. So yes, so just again just to recap Arm A is hormone receptor positive, Arm B is triple-negative just like monotherapy, Arm C is the combination with our proprietary PD-L1 Probody pacmilimab. So the revised guidance remains for Arms A and B in 2022. Arm C, it's like at this point, we're not going to be more specific than that. I think given the evolution of the macro environment and just the uncertainties around COVID, we're going to keep that guidance pretty broad right now. We do have though, I can say through 2009 we are making progress, we do have more than 20 sites open for the study, so we have the team has made a lot of progress, we need to make more and every day is a new day in the current world.

In terms of Arm C, the combination with pacmilimab, we're pretty consistent with the guidance that that would be slower than Arms A and B, given that we're screening for both CD166 and PD-L1 that's going to be a smaller patient population. We'll have to see how that develops, we'll provide additional guidance as time moves on the timing of Arm C.

Roger Song -- Jefferies LLC -- Analyst

Yeah, in the [Phonetic] spot. Yeah everyday is a new day. So maybe just another question from me is, the earlier pipeline program during something like the cytokines derivative program, which is very exciting, just any updates from that?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Roger could you repeat which program. I didn't quite get it?

Roger Song -- Jefferies LLC -- Analyst

Yeah. Just any update for your cytokine derivative program...

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah.

Roger Song -- Jefferies LLC -- Analyst

Any other kind of earlier program?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah, [Indecipherable]. And as I mentioned in my remarks, we're really excited about where we are on the platform, the work that we've done much of which we've now published in peer-reviewed form is demonstrating the utility of the Probody approach across multiple biologic modalities now extending in our most recent work to cytokines and into immune agonist antibodies with the PNAS paper on CD137. So we presented some work earlier this year on interferon alpha 2b, a really unique approach to marketing that cytokine, which I think there's general agreement that there is enormous potential for focusing or harnessing the clinical activity of that particular biology if we can increase therapeutic window. Our preclinical data supports that we have open therapeutic window when moving that asset further into preclinical development. We're still in lead optimization, I would like to say, but certainly moving it forward. And we continue to look at bispecifics and we'll continue to apply the platform to drug conjugates to get undruggable targets. So a lot of potential. I also mentioned on the call, our EGFR CD3 program, which is really a big idea in bispecifics, we know from work that is previously published by Micromet some years ago that EGFR in CD3 bispecific form is a very difficult target to address. We're bringing our masking technologies there, so attempts to open a therapeutic window. And as I mentioned, we're working toward getting that IND on file by the end of this year.

Roger Song -- Jefferies LLC -- Analyst

Got it. Thank you for all the other comment. Thank you.

Operator

Our next question comes from the line of Joe Catanzaro from Piper Sandler. Your line is now open.

Joseph M. Catanzaro, Ph.D. -- Piper Sandler -- Analyst

Great, thanks so much for taking my questions here. So, I mean, you had mentioned that for CX-2009, it was a new study that required new site initiations, so it sounds like in contrast 2029, the Phase II cohorts just rolled over from the Phase I and didn't require new site initiations, can you confirm that and is that the case for all expansion cohorts or did some tumor types, i.e. DLBCL requires some new sites to open up and enroll patients. Thanks.

Amy C. Peterson, M.D. -- Executive Vice President, Chief Development Officer

Sure. Thanks, Joe for the question. Yeah. To confirm the 2029 study was designed as a Phase one-2 study with expansion and continuing at sites that were open, which allowed us to continue enrollment. As you point out there are interesting novel cohorts and we did look at activating new sites to help boost enrollment, but the continuation of enrollment was allowed primarily due to the continuation of the study at the already open activated sites.

Joseph M. Catanzaro, Ph.D. -- Piper Sandler -- Analyst

Okay, got it. That's helpful. And then I think you guys had previously guided toward data potentially by the end of the year from both the lung cancer and head and neck, but it sounds like may you backtrack a little if I heard correctly that we could expect at least one cohort worth of data of the four.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah, I wouldn't describe that as much as a backtrack, I think we're generally on track with prior guidance.

Joseph M. Catanzaro, Ph.D. -- Piper Sandler -- Analyst

Okay, got it. That's helpful. Thanks for taking my question.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

You're welcome.

Operator

Our next question comes from comes from the line of Boris Peaker from Cowen. Your line is now open.

Vinni Trehan -- Cowen & Company LLC -- Analyst

Hi, thanks. This is Trehan [Phonetic] for Boris. For CX-2009, are you still seeing around 50% of patients -- triple-negative patients expressing CD166 at a high level. And then just thinking through for Arm C, are you getting a sense of how many triple-negative patients express both CD166 and PD-L1?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Hi. Yeah, great question. We continue to evaluate target expression across these Arms in the Phase II study. Nothing to really comment on right now, but that continues to be an important component of the study, as we continue to learn and we'll continue to learn about the relationship between CD166 expression and response and the CD166 expression across these different patient populations, so continues to be very much work in progress.

Vinni Trehan -- Cowen & Company LLC -- Analyst

All right, great. Thank you.

Operator

Our next question comes from the line of Etzer Darout from Guggenheim. Your line is now open.

Paul Jeng -- Guggenheim Securities, LLC -- Analyst

Great, thanks for taking the question. This is Paul [Phonetic] on for Etzer. Just one from us for your EpCAM program, the CX-2043, have the supply chain issues, you sort of discussed last quarter have been resolved and is there any updates your IND plan for this program. Thanks.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah, thanks for the question. And I actually neglected to mention EpCAM where I was to do my recap of our early pipeline earlier on in response to Roger's question. Yes. So we've made progress there. And just to recap the challenge that we ran into was relating to the DM21 payload, which is a next-gen [Phonetic] ravtansine. We've made a lot of progress there. We're still looking at what that timeline is going to be. So there's no formally updated guidance, but we are making progress with the program. With EpCAM generally as a target, which we continue to be highly interested in.

Paul Jeng -- Guggenheim Securities, LLC -- Analyst

Great, thanks so much.

Operator

Our next question comes from the line of Peter Lawson from Barclays. Your line is now open.

Peter Lawson, DPhil (Oxon) -- Barclays -- Analyst

Thanks Sean. Just on, I guess the CD71 data, which I'm just trying to piece it together. So, I think last time you've got -- you suggesting that the head and neck and the lung would see at the end of the year. Is that still the case and then DLBCL kind of next year, is that the right order until we get kind of data sets, year-end for head-neck and lung?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yes. So the -- again those four cohorts of head-neck, lung, esophageal and DLBCL. The first two, were obviously selected based on data that we saw in the Phase I dose escalation activity that we saw in Phase I and obvious choices of Phase 2 expansions and I would say yes. Generally, on track for those two cohorts to present updates by the end of the year as with the others following thereafter.

Peter Lawson, DPhil (Oxon) -- Barclays -- Analyst

Got you. And the venue for that would be more of a press release, then the conference.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

We haven't disclosed the strategy at this point, Peter. We will provide further information as we go further through the year.

Peter Lawson, DPhil (Oxon) -- Barclays -- Analyst

Got you. And the breast cancer delay, like triple-negative and HR positive HER-2 negative was that predominantly driven by these kind of new site in activations or was there anything else that we should be thinking about?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah, I was wondering a COVID thing and as I said, we've got a pretty decent number of sites open, lot of those come on fairly recently. The team is really working all hours to get this, let's bring this study in, we're excited about this asset. We want to see to data as much as anybody else. But it's a tough operating environment right now to get new sites initiated. I think you'll be hearing that from others. And that's, we're certainly seeing a lot of enthusiasm from our investigators, I'll take take you back to our analyst event earlier this year, where you heard starts aligning talk about the potential of praluzatamab ravtansine, and so, yeah, this is an operational challenge and we just got to keep hovering through.

Peter Lawson, DPhil (Oxon) -- Barclays -- Analyst

Okay, thanks for the update.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

You're welcome.

Operator

At this time, I would like to hand the conference back over to Chau Cheng for his closing remarks.

Chau Cheng -- Vice President, Investor Relations and Corporate Communications

So, on behalf of the executive team, I'd like to thank you all very much for joining us this afternoon. We look forward to updating you in the future on our ongoing progress.

Operator

[Operator Closing Remarks]

Duration: 30 minutes

Call participants:

Chau Cheng -- Vice President, Investor Relations and Corporate Communications

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Amy C. Peterson, M.D. -- Executive Vice President, Chief Development Officer

Carlos Campoy -- Senior Vice President and Chief Financial Officer

Anupam Rama -- JP Morgan

Roger Song -- Jefferies LLC -- Analyst

Joseph M. Catanzaro, Ph.D. -- Piper Sandler -- Analyst

Vinni Trehan -- Cowen & Company LLC -- Analyst

Paul Jeng -- Guggenheim Securities, LLC -- Analyst

Peter Lawson, DPhil (Oxon) -- Barclays -- Analyst

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